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davol orthopaedic autotransfusion system
Davol
Summary: The Davol Orthopaedic Autotransfusion System is a medical device used to collect and reinfuse a patient's own blood during orthopedic surgeries. It is primarily used by orthopedic surgeons to minimize the need for donor blood transfusions.
FDA Clearance Information
Pathway
510K
Number
K914119 ↗
Decision Date
December 3, 1992
Product Code
CAC
Device Class
Class 2
Evidence
0 studies
The Davol Orthopaedic Autotransfusion System was cleared by the FDA through the 510(k) pathway on December 3, 1992. It is manufactured by Davol and is classified as a Class 2 medical device.
What It Is
The Davol Orthopaedic Autotransfusion System is designed to collect, filter, and reinfuse a patient's own blood during surgical procedures, particularly in orthopedics. This system helps reduce the need for allogeneic blood transfusions, thereby minimizing the risks associated with blood-borne infections and immune reactions. The device operates by suctioning blood from the surgical site, filtering it to remove debris, and then returning it to the patient's circulation.
Clinical Applications
This device is commonly used in orthopedic surgeries such as joint replacements and spinal surgeries where significant blood loss is anticipated. It is particularly beneficial in settings where blood conservation is critical, such as in patients with rare blood types or those who refuse blood transfusions for personal reasons. The system is typically used in hospital operating rooms by surgical teams specializing in orthopedics.
Indications for Use
The FDA indications for this device include its use in procedures where blood loss is expected, allowing for the collection and reinfusion of the patient's own blood. It is suitable for patients undergoing orthopedic surgeries who may benefit from autologous blood transfusion.
Practical Considerations
The system is typically compatible with standard surgical suction equipment and can be integrated into existing surgical workflows. Clinicians should ensure proper setup and monitoring to optimize blood collection and reinfusion. Familiarity with the device's operation and maintenance is essential for effective use.
Frequently Asked Questions
What is the Davol Orthopaedic Autotransfusion System used for?
It is used to collect and reinfuse a patient's own blood during orthopedic surgeries to minimize the need for donor blood transfusions.
What specialties typically use this device?
Orthopedic surgeons primarily use this device in surgical settings, particularly during procedures with significant blood loss.
What are the FDA-cleared indications?
The device is indicated for use in surgeries where blood loss is expected, allowing for autologous blood collection and reinfusion.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.